Pilot Study of BAO-G Technique in TAAA Endovascular Repair

NCT06534281 | Enrolling By Invitation Early Phase 1

• 1 other identifier: BAO-G-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of thoracoabdominal aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to evaluate the safety and efficacy of BAO-G in thoracoabdominal aortic aneurysm endovascular repair.

Conditions

Aortic Aneurysm, Thoracoabdominal

Keywords

BAO-G technique; thoracoabdominal aortic aneurysm; iliac-branched devices; endovascular repair

Outcome Measures

Primary Outcomes (3)

• Rate of visceral branch patency

  the patency of visceral branches measured by radiological test

  Month 0, 3, 6, 12, and annually after surgery

• Incidence of endoleak

  The incidence of endoleak measured by radiological test

  Month 0, 3, 6, 12, and annually after surgery

• Incidence of re-operation

  The incidence of re-operation for any adverse events, confirmed by medical record and outpatient follow up

  Month 0, 3, 6, 12, and annually after surgery

Secondary Outcomes (4)

• Incidence of organ ischemia

  Month 0, 3, 6, 12, and annually after surgery

• Incidence of acute kidney injury

  perioperative period

• Incidence of acute liver function injury

  perioperative period

• Incidence of acute pancreatitis

  perioperative period

Study Arms (1)

BAO-G group

EXPERIMENTAL

Procedure: BAO-G

Interventions

BAO-G PROCEDURE

Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.

BAO-G group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with TAAA, confirmed by aortic CTA.
• TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
• Informed consent signed.

You may not qualify if:

• were pregnant.
• had a history of previous endovascular or open repair.
• had other contraindications of endovascular treatment.
• Uncontrolled autoimmune disease.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)